Staff View: Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial

BackgroundA decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent res...

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Main Authors:	Otto, Sylvia, Diaz, Victor Alfonso Jimenez, Weilenmann, Daniel, Cuculi, Florim, Nuruddin, Amin Ariff, Leibundgut, Gregor, Alfonso, Fernando, Wan Ahmad, Wan Azman, Pyxaras, Stylianos, Rittger, Harald, Steen, Philip, Gaede, Luise, Schulze, Christian, Woehrle, Jochen, Rosenberg, Mark, Waliszewski, Matthias W. W.
Format:	Article
Published:	BMC 2023
Subjects:	R Medicine (General)
Online Access:	http://eprints.um.edu.my/38395/
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spelling	my.um.eprints.383952023-11-22T07:47:47Z http://eprints.um.edu.my/38395/ Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial Otto, Sylvia Diaz, Victor Alfonso Jimenez Weilenmann, Daniel Cuculi, Florim Nuruddin, Amin Ariff Leibundgut, Gregor Alfonso, Fernando Wan Ahmad, Wan Azman Pyxaras, Stylianos Rittger, Harald Steen, Philip Gaede, Luise Schulze, Christian Woehrle, Jochen Rosenberg, Mark Waliszewski, Matthias W. W. R Medicine (General) BackgroundA decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.MethodsThe objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.DiscussionSince there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. BMC 2023-03 Article PeerReviewed Otto, Sylvia and Diaz, Victor Alfonso Jimenez and Weilenmann, Daniel and Cuculi, Florim and Nuruddin, Amin Ariff and Leibundgut, Gregor and Alfonso, Fernando and Wan Ahmad, Wan Azman and Pyxaras, Stylianos and Rittger, Harald and Steen, Philip and Gaede, Luise and Schulze, Christian and Woehrle, Jochen and Rosenberg, Mark and Waliszewski, Matthias W. W. (2023) Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial. BMC CARDIOVASCULAR DISORDERS, 23 (1). ISSN 1471-2261, DOI https://doi.org/10.1186/s12872-023-03187-x <https://doi.org/10.1186/s12872-023-03187-x>. 10.1186/s12872-023-03187-x
institution	Universiti Malaya
building	UM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaya
content_source	UM Research Repository
url_provider	http://eprints.um.edu.my/
topic	R Medicine (General)
spellingShingle	R Medicine (General) Otto, Sylvia Diaz, Victor Alfonso Jimenez Weilenmann, Daniel Cuculi, Florim Nuruddin, Amin Ariff Leibundgut, Gregor Alfonso, Fernando Wan Ahmad, Wan Azman Pyxaras, Stylianos Rittger, Harald Steen, Philip Gaede, Luise Schulze, Christian Woehrle, Jochen Rosenberg, Mark Waliszewski, Matthias W. W. Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
description	BackgroundA decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.MethodsThe objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.DiscussionSince there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.
format	Article
author	Otto, Sylvia Diaz, Victor Alfonso Jimenez Weilenmann, Daniel Cuculi, Florim Nuruddin, Amin Ariff Leibundgut, Gregor Alfonso, Fernando Wan Ahmad, Wan Azman Pyxaras, Stylianos Rittger, Harald Steen, Philip Gaede, Luise Schulze, Christian Woehrle, Jochen Rosenberg, Mark Waliszewski, Matthias W. W.
author_facet	Otto, Sylvia Diaz, Victor Alfonso Jimenez Weilenmann, Daniel Cuculi, Florim Nuruddin, Amin Ariff Leibundgut, Gregor Alfonso, Fernando Wan Ahmad, Wan Azman Pyxaras, Stylianos Rittger, Harald Steen, Philip Gaede, Luise Schulze, Christian Woehrle, Jochen Rosenberg, Mark Waliszewski, Matthias W. W.
author_sort	Otto, Sylvia
title	Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
title_short	Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
title_full	Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
title_fullStr	Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
title_full_unstemmed	Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial
title_sort	crystalline sirolimus-coated balloon (cscb) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the score trial
publisher	BMC
publishDate	2023
url	http://eprints.um.edu.my/38395/
_version_	1783876664274452480
score	13.211869

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial

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